Medication info

Zenbise Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Ranitidine Hydrochloride›84mg / 1 tabletTripotassium Bismuth Dicitrate›100mg / 1 tabletSucralfate Hydrate›300mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
White, round, film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201904406 · Approved 2019.06.27

This product's status changed to Expired on 2024.06.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal diseases such as gastric and duodenal ulcers, gastritis
Who takes it
Adults
Adult dose
Usually administered orally as 2 tablets twice a day before breakfast and bedtime, regardless of meals. 1) Gastric and duodenal ulcers: Administer 2 tablets twice a day or 4 tablets once a day before bedtime. 2) Gastroesophageal reflux disease: Administer 2 tablets twice a day for 8 weeks or 4 tablets once a day before bedtime. In severe cases, the dosage may be increased to 4 tablets four times a day. 3) Zollinger-Ellison syndrome: Start treatment with an initial dosage of 2 tablets three times a day and may increase as needed. In severe cases, 6 g of ranitidine per day can be administered under physician's direction. 4) Upper gastrointestinal bleeding due to peptic ulcer, acute stress ulcer, and acute gastric mucosal lesions: Once oral administration is possible, switch from injection to oral administration, taking 2 tablets twice a day. 5) Pre-operative dosing (preventing Mendelson’s syndrome): Administer 2 tablets 2 hours before anesthesia induction. It is also advisable to take 2 tablets the night before surgery.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Treatment of gastrointestinal diseases such as gastric and duodenal ulcers, gastritis

  • Gastric ulcer
  • duodenal ulcer
  • gastritis
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson's syndrome
  • post-operative ulcer
  • gastric ulcer due to non-steroidal anti-inflammatory drugs
  • duodenal ulcer due to non-steroidal anti-inflammatory drugs
View approved original text

This medication is effective for gastrointestinal diseases such as gastric and duodenal ulcers, gastritis, and gastroesophageal reflux disease. It is also used to treat conditions related to excessive gastric acid secretion, such as Zollinger-Ellison syndrome. It may be administered to prevent Mendelson's syndrome during pre-operative anesthesia and is helpful in preventing ulcers post-surgery. It is also used to treat gastric and duodenal ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). This medication is useful in improving various gastrointestinal-related problems.

How to take

Adult dose

Usually administered orally as 2 tablets twice a day before breakfast and bedtime, regardless of meals. 1) Gastric and duodenal ulcers: Administer 2 tablets twice a day or 4 tablets once a day before bedtime. 2) Gastroesophageal reflux disease: Administer 2 tablets twice a day for 8 weeks or 4 tablets once a day before bedtime. In severe cases, the dosage may be increased to 4 tablets four times a day. 3) Zollinger-Ellison syndrome: Start treatment with an initial dosage of 2 tablets three times a day and may increase as needed. In severe cases, 6 g of ranitidine per day can be administered under physician's direction. 4) Upper gastrointestinal bleeding due to peptic ulcer, acute stress ulcer, and acute gastric mucosal lesions: Once oral administration is possible, switch from injection to oral administration, taking 2 tablets twice a day. 5) Pre-operative dosing (preventing Mendelson’s syndrome): Administer 2 tablets 2 hours before anesthesia induction. It is also advisable to take 2 tablets the night before surgery.

Precautions

This medication should not be used in patients receiving dialysis treatment or those allergic to this medication or its components. It is also not safe to administer to patients with a history of acute porphyria. Administration should be avoided in patients with impaired renal function, those who have undergone upper gastrointestinal surgery, pregnant women or women with a possibility of pregnancy, premature infants, and neonates, as well as patients on potassium-restricted diets. Patients with impaired liver function, a history of drug allergies, the elderly, and patients with a history of renal dysfunction should use this medication with caution. Extra care should be taken if it is used in conjunction with non-steroidal anti-inflammatory drugs, and patients with gastric ulcers or middle-aged patients with newly appeared dyspeptic symptoms should use it only after excluding the possibility of gastric cancer. Patients with gastric or duodenal ulcers infected with Helicobacter pylori should undergo eradication therapy. Careful monitoring is required for severely ill patients in intensive care, hypophosphatemia patients, and those with swallowing difficulties. This drug can rarely cause severe allergic reactions such as anaphylactic shock; therefore, symptoms should be closely monitored during administration. Allergic reactions such as skin rash, urticaria, angioedema, fever, bronchospasm, and hypotension may occur, and if any of these symptoms appear, the use should be immediately discontinued. Rarely reported side effects include decreased blood cell count, liver dysfunction, arrhythmia, gastrointestinal symptoms, and psychiatric neurological symptoms; any abnormal symptoms should be discussed with healthcare providers. Long-term use is not recommended, and it is safest to use the minimal effective dose while closely observing the treatment progress. Particularly in the elderly or immunocompromised patients, the risk of pneumonia may increase; caution is advised. Dizziness or drowsiness may occur, so driving or operating hazardous machinery is advised against. This medication may interact with other drugs, so if there are any concomitant medications, it is essential to inform healthcare providers. Caution is particularly needed when combined with anticoagulants, certain antibiotics, or anticonvulsants, and the dosage intervals may need adjustment. Pregnant or breastfeeding women should not use this medication, and safety in children has not been established, so use is not recommended. In case of overdose, emergency measures such as vomiting or gastric lavage are necessary, and in some cases blood dialysis may be used to remove the drug. This medication can reduce gastric acid secretion and promote bacterial growth in the gastrointestinal tract, so long-term use may necessitate ophthalmic examinations.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, bronchospasm, shock (anaphylactic shock), severe rash with high fever, blisters, shedding skin, pain in mucous membranes of mouth/eyes, breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, hepatitis, sudden and severe headache, lightning-like headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly decreased urine output

Mild side effects

Skin rash, angioedema, fever, hypotension, chest pain, granulocytopenia, leukopenia, thrombocytopenia, elevated serum enzyme levels, agranulocytosis, pancytopenia, bone marrow suppression, aplastic anemia, eosinophilia, temporary and reversible increases in AST, ALT, r-GTP, ALP, tachycardia, bradycardia, atrioventricular block, premature ventricular contractions, vasculitis, nausea, vomiting, constipation, diarrhea, abdominal distension, abdominal pain, indigestion

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White, round, film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.